Purdue Pharma's Crushing Defeat

Jacob Sullum | May 10, 2007

Purdue Pharma has pleaded guilty to "misbranding" OxyContin by telling doctors that the timed-release version of oxycodone had a lower potential for abuse and addiction than other narcotic painkillers. It will pay some $600 million to resolve the criminal and civil charges stemming from its OxyContin marketing campaign. Since the company has admitted that its representatives falsely reassured doctors with fake scientific charts, among other fraudulent techniques, it is by no means blameless. But it's worth pointing out that Purdue Pharma is essentially being held responsible for the behavior of patients and black-market OxyContin buyers who deliberately crushed the pill to get all the oxycodone at once and then snorted or injected it. While the company might have anticipated this problem, it was not completely out of line in suggesting that the pills when taken as directed posed a lower addiction risk. "Accidental" addiction among legitimate patients taking narcotics for pain appears to be rare, but its incidence is greatly exaggerated by the government's anti-drug propaganda, and Purdue Pharma was largely responding to this perceived danger.

While OxyContin was oversold as an answer to the government's concern about nonmedical use, timed release was an important painkiller innovation, delivering steady relief over an extended period instead of the ups and downs associated with shorter-acting opioids. Purdue Pharma also makes MS Contin, a timed-release morphine tablet that predates OxyContin but has not attracted anything like the more notorious drug's sensational press coverage or black market following (which tend to feed each other).

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|5.10.07 @ 1:18PM|#

Dear god! Salespeoples lied?

Say it ain't so!

|5.10.07 @ 1:26PM|#

it was not completely out of line in suggesting that the pills when taken as directed posed a lower addiction risk.

But it was completely out of line in suggesting that they posed a lower risk of abuse. "Time-release" just means you have to crush it more thoroughly.

scandalrag|5.10.07 @ 1:34PM|#

In other, much more unexpected drug war news:

http://www.lvrj.com/news/7436841.html

|5.10.07 @ 1:52PM|#

I think it is very telling that most of the fine will go to Federal, State and local police departments.
So the incentive here is?

Sal Paradise|5.10.07 @ 1:52PM|#

"but its incidence is greatly exaggerated by the government's anti-drug propaganda, and Purdue Pharma was largely responding to this perceived danger."

It's still fraud, are we OK with fraud as long as it's for the "right" reasons?

David Ross|5.10.07 @ 2:01PM|#

I may be a heartless, selfish, capitalist running-dog exploiter of the world's workers but at least I admit to it. I can't work up any sympathy for these weasels. Screw 'em.

|5.10.07 @ 2:11PM|#

Memo to Jake: When defending a big drug company guilty of fraudulent behavior, DO NOT USE THE PHRASE "was not completely out of line." Maybe there's a good case to be made for cutting that $600 million in half, Jake, or even in fourths, but I think it requires a little more legwork.

|5.10.07 @ 2:30PM|#

I may be a heartless, selfish, capitalist running-dog exploiter of the world's workers but at least I admit to it. I can't work up any sympathy for these weasels. Screw 'em.

ummm

sooo...

Drugs should be legal right?

And in a society with legal drugs is it not unreasonable for a company to make a painkiller when used as intended will limit the amount of side effects, ie addiction, and to sell that painkiller uses advertisements and marketing that highlight its advantage?

David Ross|5.10.07 @ 2:59PM|#

joshua, sure, but "highlighting its advantage" doesn't mean showing off false charts. Last I heard, under civil law, if you lie to your customers then they can sue you. Purdue lied and got sued. End of story AFAIAC.

|5.10.07 @ 3:03PM|#

See, I wasn't a druggie, I was defrauded.

Lupito41|5.10.07 @ 3:10PM|#

"See, I wasn't a druggie, I was defrauded."

Mega Dittos.

|5.10.07 @ 3:27PM|#

It's still fraud, are we OK with fraud as long as it's for the "right" reasons?

Would you agree that there's a difference between fraud that causes a little damage, and fraud that causes massive damage.

Dave W.|5.10.07 @ 3:43PM|#

Would you agree that there's a difference between fraud that causes a little damage, and fraud that causes massive damage.

I would agree that there is a difference between an award large enough to disincentivize future lying, and an award too small to disincentivize future lying.

If you want to know how big the award has to be to truly disincentivize future dishonesty, then you can get a good rough estimate by looking at how many legitimate journalists are in a company's Rolodex. One million dollars in damages for every legit journalist there is a good rule of thumb.

Drug companies have prerogatives in this society that you and I do not, and with superior prerogatives come superior responsibilities, a punctilio of honor most sensitive and all that.

|5.10.07 @ 3:53PM|#

It's still fraud, are we OK with fraud as long as it's for the "right" reasons?

Yes, we are... or do you feel that Harriet Tubman should have gone to jail, or the family that helped Anne Frank hide were criminals?

Remember, the drug really did work as promised for the consumers. No-one taking the drug was lied to or harmed. What was lied about was strictly information that would only concern drug war zealots.

|5.10.07 @ 4:13PM|#

I would agree that there is a difference between an award large enough to disincentivize future lying, and an award too small to disincentivize future lying.

So you don't see any need for proportionality between the damage done and the punishment inflicted?

SIV|5.10.07 @ 7:03PM|#

"MS Contin, a timed-release morphine tablet that predates OxyContin but has not attracted anything like the more notorious drug's sensational press coverage or black market following (which tend to feed each other"

So, off the top of head, MS Contin is schedule II while Oxycontin was initially schedule III ?
Just a guess.
That would lead to much easier access through the tight-assed "gateway"

Morphine sulfate has near no effect when snorted and is not very potent orally (totally rocks iv though).

There are pharmocological differences to explain the appeal of oxy over MS.

I'd rather the State get the money than lawyers
and "victims"

D.A. Ridgely|5.10.07 @ 7:10PM|#

I'll hate myself in the morning for agreeing even a tiny bit with Dave W here, but if the point of "punitive" damages award is to make it too painful for a company to repeat the behavior, then no, there is no direct correlation between the damage done and the size of the award. If you stick to a pure actual harm done basis, then you get people at Ford calculating whether it's more expensive to change the gas tank for the entire model or just pay off the likely wrongful death awards.

Actually, tort law isn't a bad private mechanism in principle to do this sort of market correcting. The problem is that the bulk of the awarded damages go to lawyers "acting as private attorneys general." If we could figure out how little they'd be willing to take and then direct the rest of the punitive damages to something more useful than a senior partner's trophy wife alimony payments, it wouldn't be a bad system at all.

SIV|5.10.07 @ 7:34PM|#

"Cheese" hysteria on Fox News!

Kiddie heroin that is cheaper than bubblegum and popular with 7 year olds.

Tylenol PM mixed with "black tar".
And the guy who first mixed coke and baking soda
thought he had a good idea........

|5.10.07 @ 11:12PM|#

"But it's worth pointing out that Purdue Pharma is essentially being held responsible for the behavior of patients and black-market OxyContin buyers who deliberately crushed the pill to get all the oxycodone at once and then snorted or injected it."

That's the way it works in our legal system. If you sneeze and drive into someone's yard and run over their $50 mailbox, you owe them $50. If you make exactly the same maneuver and cause their wood stove to fall over and burn down the house, you owe them a new house.

Same thing with how much trouble you get into if you irresponsibly fire your gun into the night; sometimes, it just depends if someone turned left or right half a mile away at a particular moment.

I'm not 100% sold that this advances justice to the maximum degree, but it's hardly a unique situation for Purdue to get into more trouble because of how their actions played out among other people.

|5.11.07 @ 6:50AM|#

I'll hate myself in the morning for agreeing even a tiny bit with Dave W here, but if the point of "punitive" damages award is to make it too painful for a company to repeat the behavior, then no, there is no direct correlation between the damage done and the size of the award.

So you're comfortable with punishments that are grossly disproportionate to the harm done?

That's the way it works in our legal system.

Actually, this is quite an innovation. It used to be that the intervening criminal act of a third party was a defense. If someone stole my car and killed someone, I wasn't responsible, even if I negligently left the key in the ignition.

|5.11.07 @ 9:02AM|#

The addiction and abuse potential for oxycodone was well known before OxyContin hit the market. And since OxyContin is basically a time released form of oxycodone, why would anyone, especially doctors, believe it had a lower abuse/addiction potential?

Dave W.|5.11.07 @ 9:30AM|#

And since OxyContin is basically a time released form of oxycodone, why would anyone, especially doctors, believe it had a lower abuse/addiction potential?

Because of Perdue Pharma's "fake scientific charts among other fraudulent techniques," maybe.

So you're comfortable with punishments that are grossly disproportionate to the harm done?

In a criminal case, like this, sure. Even "proportionality" required by the no-cruel-and-unusual-punishments requirement (if any) would clearly not extend to a criminal fine needing to be proportional to the damages.

Dave W.|5.11.07 @ 9:44AM|#

oh, and btw, I have issues, even problems, with punitive damages in civil cases, both in theory and in practice. However, this case does not seem to be a particularly great vehicle for discussing those concerns because:

1. it is criminal (at least in some undisclosed proportion).

and

2. Drug safety information (and profitable) is serious business -- the rules that apply to widgets neither can or should be applied to safety of the food supply and accurate info about expected side effects of drugs (with unintended narcotic addiction being the expected side effect here).

Hopefully Mr. Sullum can find a recent case where the punitive damages truly are ridiculous. It seems to me that those cases are getting harder and harder to find over the past decade or so. Trying to shoehorn this case into that longstanding paradigm is quite a stretch, even by the prevailing corporatarian standards around here.

Dave W.|5.11.07 @ 9:50AM|#

"needing to be proportional to the damages"

should have been:

--needing to be proportional to the compensatory damages (as that term of art is understood in the civil law)--

(wish they would add an edit fcn to this bd!)

|5.11.07 @ 10:33AM|#

It does my heart good to see this company finally come to justice. Just think of how many lives they have ruined with their OxyContin policies for sales. Now maybe the company will not have any more sales Rally's for this product purported to make them the number one pharmaceutical company in the world!
No amount of money can bring back the lives these policies cost. I think the fine should not go to law enforcement, but a fund should be set up to reimburse those families who lost their loved ones as a result of those policies.

|5.11.07 @ 11:49AM|#

OxyContin provide significantly improved pain relief for many patients. The time release aspect of the medication allowed patients to take one pill and get effective pain relief for a long period of time.

This is a significant especially since many patients (cancer) have difficulty swallowing. Being able to take one pill and get sustained pain relief significantly improved their quality of life.

What bought this settlement about was years of attacks on the OxyContin by

1.) Trial lawyers who saw a big corporation with deep pockets they could sue.

The lawyers sued for deaths of people who had died while abusing the drug by crushing it to destroy the sustained release properties of the product.

Many of the dead people were intoxicated with multiple drugs at the time of their death. It could be argued that the alcohol or cocaine is what killed them but your average coke dealer is not so easy to sue.

2.) The usual suspects involved in the drug war panic industry. Remember all of the overblown stories about hillbilly heroin, the latest drug plague, etc, etc.

This will result in more people in more situations suffering from more pain. Once again we will punish legitimate patients in tremendous pain just to make a politically correct point courtesy of the DEA and the trial lawyers.

It is disappointing to see how many people who are ignorant of the histroy of OxyContin and its utility in pain management cheer on the results of this particular witch hunt.

Dave W.|5.11.07 @ 12:19PM|#

The lawyers sued for deaths of people who had died while abusing the drug by crushing it to destroy the sustained release properties of the product.

Desperate people do desperate things. For a responsible doctor, the real question is at what margin is a patient's pain so bad that you put a patient in a position where there is a risk that, over the long run, they get so desperate that they start doing this.

Sometimes pain is bad enough that this risk is justified.

Sometimes lesser pain killers should be used to avoid having people face this risk on a slight pretext.

Normally, this is a paternalistic stance to take. I don't want the state or doctors or anyone acting as gatekeepers for mild stuff like alcohol, cigarettes or mj. nevertheless, I am more comfortable with some gatekeeping on morphine, heroin and oxycontin. it is just the nature of those drugs and their addictions.

However, hard or soft the gatekeeper is on OxyContin (and I prefer a softer gatekeeper than what we have now), that gatekeeper should be a medical professional and should be able to rely on scientific data supplied by the pharmaceutical company. As much as a patient promises in advance not to crush the pills and try to get extra pills on the side, I think those assurance need to be taken with something of a grain of salt. Perdue wanted physicians to take the assurances with a small grain. Turns out that a big grain would have been more appropos. Whoops. Sorry, but that matters.

This fake graphs stuff is very not-helpful for people who would like to see an incrementally more laissez-faire approach to pharmaceutical drugs in the US. I mean, you guys get that, don't you? Jacob? Somebody?

|5.11.07 @ 2:25PM|#

Dave W.

Your ignorance on this topic is painful to the eyes.

It is not the pain patients who were crushing pills and snorting them it was drug abusers who got diverted OxyContin.

You also said

Sometimes lesser pain killers should be used to avoid having people face this risk on a slight pretext.

Given that the DEA has had a disturbing tendency to prosecute doctors who provide adequate pain relief drugs like OxyContin tend to be used only after milder classes of drugs fail to provide adequate pain relief.

Opiate pain relievers are underused by physicians not over used.

Dave W.|5.11.07 @ 2:40PM|#

It is not the pain patients who were crushing pills and snorting them it was drug abusers who got diverted OxyContin.

here is how it works:

1. a pain patient (we'll call him Rush) gets a legit pain prescription for slow release OxyContin.

2. Rush's legit use of slow release OxyContin morphs into an addiction, with Rush starting to do despreate things like faking pain, crushing pills, snorting and scoring non-prescribed narcotics from his housekeeper.

3. Rush and his family now how a big problem on its hands, medical, legal, work-wise, you name it.

Now sometimes this is a risk worth taking. A lot depends on how bad Rush's pain was in the first place. However, we don't want physicians getting patients started on this potential road unless the pain is sufficiently serious. For physicians to develop good judgment in balancing pain against addiction risk, they need good info on addiction risk. That is what Purdue lied about here, and that is what they are being punished for. You are acting like one is either a pain patient, or a drug addict. The problem is that you can be both. Slow release OxyContin might still be a good product -- the optimum for some, or even many pain patients. the point of this case, however, is that they don't get to lie to doctors about the potential downside.

|5.11.07 @ 2:43PM|#

More ignorance from Dave W

Normally, this is a paternalistic stance to take. I don't want the state or doctors or anyone acting as gatekeepers for mild stuff like alcohol, cigarettes or mj.

Over time cigarettes and alcohol cause biochemical destruction to the body ever hear of chronic obstructive pulmonary disorder, or emphysema, how about cirrhosis? And as a minor detail they are not effective for controlling pain.

On the other hand opiates are well tolerated, cause no biochemical damage, and acutally relieve pain.

The ignorance continues to stack up Dave W says

nevertheless, I am more comfortable with some gatekeeping on morphine, heroin and oxycontin. it is just the nature of those drugs and their addictions.

Allow drugs that cause damage, aren't effective, and have no medical use (tobacco and alcohol). Restrict drugs that are effective and safe (opiates). Welcome to the upside down ignorance of Daves world.

Stupidity like that is why we get to see the sight of terminal cancer patients being denied adequate pain relief in the mistaken belief that they might become addicted.

Dave W's post would be funny if it were not for the fact that ignorant opinions like his cause immense amounts of human suffering.

Dave W.|5.11.07 @ 2:53PM|#

,i>Stupidity like that is why we get to see the sight of terminal cancer patients being denied adequate pain relief in the mistaken belief that they might become addicted.

I think we agree on the ultimate goal of getting people who really need it access to the latest and greatest narcotics.

The difference is that you see Purdue's lying as helpful toward that end, while I see it as profoundly unhelpful.

That is the difference between us right there.

Robert|5.11.07 @ 4:51PM|#

"This will result in more people in more situations suffering from more pain. Once again we will punish legitimate patients in tremendous pain just to make a politically correct point courtesy of the DEA and the trial lawyers."

How? It's not being taken off the market.

|5.11.07 @ 9:07PM|#

RC Dean,

"Actually, this is quite an innovation. It used to be that the intervening criminal act of a third party was a defense. If someone stole my car and killed someone, I wasn't responsible, even if I negligently left the key in the ignition."

Only if your action was not a criminal act. Leaving your keys in the ignition is not negligent under the legal definition.

In this case, the court decided, Perdue has committed an act that was, itself, actionable.

If you negligently left your loaded gun lying in the playground, for example, you could be facing charges if someone picks it up and shoots somebody - even if they get charged for the murder.

|5.12.07 @ 3:44PM|#

"While the company might have anticipated this problem, it was not completely out of line in suggesting that the pills when taken as directed posed a lower addiction risk. "

They were out of line unless that had actual evidence to back up the claim.

Instead, they just made shit up.

Sounds out of line to me.

|5.12.07 @ 3:46PM|#

|5.12.07 @ 3:49PM|#

"Pharma contended that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than do traditional, shorter-acting painkillers like Percocet or Vicodin.

That claim became the linchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller. "

But the claim was untrue.
Active fraud is at issue here.

If they had undertaken the aggressive marketing campaign based on actual evidence or a true feature of the drug, then there wouldn't be a case here.

You see that right?

|5.12.07 @ 6:43PM|#

Dave W said

I think we agree on the ultimate goal of getting people who really need it access to the latest and greatest narcotics.

Hard to square that statement with your calls for restricted access to useful painkillers like opiates and no restriction on access to cigarettes and alcohol which don't control pain and are damaging to the body. That position is especially entertaining given the fact that nicotine is highly addictive.

Dave W you also said

The difference is that you see Purdue's lying as helpful toward that end, while I see it as profoundly unhelpful.

Can't square that statement with the fact that I never mentioned Purdue in any of my comments.

|5.12.07 @ 6:58PM|#

Robert

To my statement of

"This will result in more people in more situations suffering from more pain. Once again we will punish legitimate patients in tremendous pain just to make a politically correct point courtesy of the DEA and the trial lawyers."

You said "How? It's not being taken off the market."

The answer to that question can be found by following this link.

Prosecution of pain control specialists

Prescribing opiates for pain relief can flag a doctor for prosecution by the DEA. So physicians soon learn not to prescribe adequate pain relief if that requires ongoing treatment with opiates.

|5.12.07 @ 7:07PM|#

The DEA, the trial lawyers, and Purdue all lied.

The DEA lied about the dangers of opiate pain relief and what was appropriate for pain relief.

The trial lawyers lied about the same thing and they lied about the circumstances related to many of the OxyContin related fatalities. In most, it not all, of the fatalities oxccontin was misused by crushing the drug. This misuse was often associated with simultaneous abuse of many other drugs.

The trial lawyers and the DEA both used the gullible, uneducated media, and its desire for sensational stories to propagate these lies.

Pudue lied about the addictive potential of drug.

None of these lies are tolerable. But somehow the lies of the DEA and the trial lawyers get ignored.

At the end of the day there is no doubt that the lies of the DEA and the trial lawyers will cause for more human suffering then the lies of Purdue ever will.

Evidence of this is the wide spread misconceptions about the science of pain control and how the human body reacts to pain and the opiates used to treat pain. Many of these misconceptions that have been seen on this thread.

|5.12.07 @ 7:10PM|#

My personal priority is adequate pain relief for those people who need. Pain relief is absolutely crucial to a good quality of life for so many people that it overwhelms the unavoidable side effect of the occasional death from misuse of opiates.

Pain patients don't have a choice with respect to their pain and to deny them adequate relief is unspeakably cruel.

Robert|5.13.07 @ 12:07PM|#

You said "How? It's not being taken off the market."

The answer to that question can be found by following this link.

Prosecution of pain control specialists

No, it can't.

Prescribing opiates for pain relief can flag a doctor for prosecution by the DEA. So physicians soon learn not to prescribe adequate pain relief if that requires ongoing treatment with opiates.

What does that have to do with false statements made to doctors in the marketing of OxyContin? Are you saying that if drug makers are allowed to lie to doctors about data regarding their products, then DEA won't take note of what they consider suspicious use of opiates?

Hooked|5.13.07 @ 8:13PM|#

I now take #120 - *) MG> of Oxy. per. month. What do I do know? 'God' help me and i hope that they 'BURN" in hell for what they have done to us inocent folks who were just looking for some pain relief........

|5.13.07 @ 8:18PM|#

Robert,

The key thing I am concerned with here is contained in you statement

then DEA won't take note of what they consider suspicious use of opiates

I am saying the overhyping of the dangers of opiates in general and OxyContin in particular allowed the trial lawyers and DEA to gin up a significant problem where none exists. That created a hysterical public demanding for people to do something.

This creates an environment that allows money seeking trial lawyers and publicity seeking prosecutors a reason to go after doctors who use opiates for pain control.

The environment is similar to the repressed memory scam and the scandal of overzealous prosecutors convicting people of abusing children when they had not.

If you read any of the links you would see how overzealous prosecutors aided by an environment of hysteria created by sensational media coverage ended up prosecuting doctors for drug dealing who were doing nothing of the sort.

Everyone is focused on Purdues wrongdoing in this case and ignoring the misdeeds of the trial lawyers, prosecutors, and media. Fair enough the article was about Purdues misdeeds.

I am simply trying to show (and apparently being pretty ineffective in explaining it) how much of the activity by the DEA and trial lawyers is far more harmful to patient care then Purdues misdeeds.

Robert|5.14.07 @ 1:04AM|#

What you haven't done is show how fining Purdue for false statements about their product makes that situation any worse:

"This will result in more people in more situations suffering from more pain. Once again we will punish legitimate patients in tremendous pain just to make a politically correct point courtesy of the DEA and the trial lawyers."

Explain. Or, explain how Purdue's making false statements about their product lessened the problem cited above.

Or, explain how curbing abuses by DEA, trial lawyers, and publicity seeking prosecutors is incompatible with stopping drug makers from lying about their products.

|5.14.07 @ 10:37AM|#

Robert,

I don't think we disagree on Purdues misdeeds. Instead of focusing only on Purdues misdeeds I have attempted to bring in the totality of the situation around OxyContin. You said

explain how curbing abuses by DEA, trial lawyers, and publicity seeking prosecutors is incompatible with stopping drug makers from lying about their products.

I would say they are not incompatible. But somehow those abuses never get curbed but company abuses regularly do.

The question is why don't the other abuses get curbed? Probably because there is a natural alliance of interests to make sure company misdeeds get lots of attention and are punished.

The other abuses, not so much.

Robert|5.14.07 @ 4:17PM|#

"Instead of focusing only on Purdues misdeeds I have attempted to bring in the totality of the situation around OxyContin."

But we've had threads on that aplenty. So it looks like you're just saying, "Never mind this, I've got something else that's more important." At least it's not HFCS.

|5.15.07 @ 6:39PM|#

Just a comment: It's funny how Purdue created a pain reliever that actually CAUSES PAIN when the user stops using it. So, for the sake of SALES, that works great. The patient actually feels pain when they stop taking oxycontin, so naturally they assume they're still in pain. When in fact it's the withdrawal of the drug itself causing the pain. Those guys are pretty smart. Lets not forget it was originally intended for terminally ill cancer patients, where it didn't really matter if they were addicted.l Purdue Pharma representatives should see jail time for what they've done. People with back pain, or a sprained wrist, or a minor surgery were being prescribed this, because they pleaded with FDA to be classified for moderate pain!

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